This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 4-arm study in adult participants with moderate to severe AD who are inadequately controlled with topical therapies or for whom such topical therapies are inadvisable and who are candidates for systemic therapy. Participants will be randomized to receive SAR444656 dose 1, dose 2, dose 3 or matching placebo. Participants who meet inclusion/exclusion criteria will be stratified for randomization by severity of AD (moderate \[baseline EASI score \<22\] versus severe \[baseline EASI score ≥22\]). The total duration of study is approximately 24 weeks, including 1 to 4 weeks for screening, 16 weeks for double-blind study treatment and 4 weeks for follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Oral Tablet
Oral Tablet
Clear Dermatology & Aesthetics Center- Site Number : 8400003
Scottsdale, Arizona, United States
Encore Medical Research of Boynton Beach- Site Number : 8400002
Boynton Beach, Florida, United States
Revival Research - Doral- Site Number : 8400007
Doral, Florida, United States
Encore Medical Research - 6600 Taft St- Site Number : 8400004
Hollywood, Florida, United States
Sullivan Dermatology- Site Number : 8400001
Miami, Florida, United States
Percent change from baseline in EASI
Eczema area severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Time frame: Week 16
Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points
Time frame: Week 16
Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline)
Time frame: Week 16
Absolute change from baseline in EASI
Time frame: Week 16
Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline)
Time frame: Week 16
Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline)
Time frame: Week 16
Change from baseline in percent body surface area (BSA) affected by AD
Time frame: Week 16
Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline
Time frame: Week 16
Percent change from baseline in weekly average of daily PP-NRS
Time frame: Week 16
Absolute change from baseline in weekly average of daily PP-NRS
Time frame: Week 16
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs
Time frame: Up to Week 20
Plasma SAR444656 concentration
Time frame: Week 0, Week 1, Week 2, Week 4, and Week 16
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ARA Professionals- Site Number : 8400017
Miami, Florida, United States
Encore Medical Research - Weston- Site Number : 8400008
Weston, Florida, United States
Wayne Health - Dearborn- Site Number : 8400009
Dearborn, Michigan, United States
UPMC Montefiore- Site Number : 8400006
Pittsburgh, Pennsylvania, United States
ACRC Trials - Carrollton - Hunt - PPDS- Site Number : 8400012
Carrollton, Texas, United States
...and 27 more locations